EP1011679B1 - Verwendung von 8-nitro-2,3,4,5-tetrahydro-1h-3-benzazepinen zur herstellung von pharmazeutischen zusammenstellungen zur behandlung von schlafstörungen - Google Patents
Verwendung von 8-nitro-2,3,4,5-tetrahydro-1h-3-benzazepinen zur herstellung von pharmazeutischen zusammenstellungen zur behandlung von schlafstörungen Download PDFInfo
- Publication number
- EP1011679B1 EP1011679B1 EP98907896A EP98907896A EP1011679B1 EP 1011679 B1 EP1011679 B1 EP 1011679B1 EP 98907896 A EP98907896 A EP 98907896A EP 98907896 A EP98907896 A EP 98907896A EP 1011679 B1 EP1011679 B1 EP 1011679B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- sleep
- treatment
- compound
- tetrahydro
- acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- the present invention relates to the use of compounds of the general formula I for the treatment of patients suffering from sleep disorders and/or sleep disturbances.
- the present invention also embraces pharmaceutical compositions comprising these compounds and the use of the compounds and their pharmaceutical compositions.
- Sleep disorders and sleep disturbances are those known to be included in the definition by those skilled in the art, which includes e.g. insomnia, agitation, restlessness.
- Benzodiazepines are widely used in the pharmacological treatment of sleep disorders and/or sleep disturbances . These compounds are endowed with numerous side effects such as amnesia, induction of tolerance and high abuse potential. Thus there exists a need for a compound in the treatment sleep disorders and/or sleep disturbances which causes less side effects than known compounds.
- USP 5470850 discloses 8-chloro- and 8-bromo-2,3,4,5,-tetrahydro-1H-3-benzazepines useful in treatment of certain disorders in the central nervous system, including sleep disturbances.
- dopamine D1 receptor antagonists including NNC 0756 ((+)-8-chloro-7-hydroxy-3-methyl-5-(2,3-dihydrobenzofuran-7-yl)-2,3,4,5-tetrahydro-1H-3-benzazepine) markedly enhance the time spent in sleep through an increase in both REM and non-REM sleep ("Differential effects of dopamine D1 and D2 receptor antagonist antipsychotics on sleep-wake patterns in the rat", Ongini et al. (1993), Journ. Pharm. Exp.
- a hypnotic should have a short half life, so that the compound, when administered at bed time, is cleared from the body in the morning. Therefore, compounds like NNC 0756, having a relatively long half life, is not well suited with respect to this indication.
- European Patent No. 0347672 describes 8-nitro-2,3,4,5-tetrahydro-1H-3-benzazepines. These compounds are described as dopamine antagonists useful as neuroleptics in the treatment of various mental disorders, e.g. manic-depressive disorders. There is no disclosure in the application of using the compounds to treat sleep disorders.
- the present invention provides a compound which can effectively be used in the treatment or prevention of sleep disorders and/or sleep disturbances, e.g. insomnia, and which has a short half life, so that the compound, when administered at bed time, is cleared from the body in the morning.
- sleep disorders and/or sleep disturbances e.g. insomnia
- (+)-5-(2,3-dihydrobenzofuran-7-yl)-7-hydroxy-3-methyl-8-nitro-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof can be used for the manufacture of a pharmaceutical composition for the treatment or prevention of sleep disorders and/or sleep disturbances.
- the compound can be used for treating or preventing sleep disorders and/or sleep disturbances.
- the compound can be useful in the treatment or prevention of sleep disorders and/or sleep disturbances, such as insomnia, i.e. delay of sleep onset, difficulty staying asleep, awakening too early.
- sleep disorders and/or sleep disturbances such as insomnia, i.e. delay of sleep onset, difficulty staying asleep, awakening too early.
- the compound can be used for treatment or prevention of sleep disorders and/or sleep disturbances in a patient.
- the term "patient” includes any mammal which could benefit from treatment of sleep disorders.
- the term particularly refers to a human patient, but is not intended to be so limited.
- the compound is prepared according to known methods, such as those described in European Patent No. 0347672.
- the compound may be prepared in the form of pharmaceutically acceptable salts, especially acid addition salts, including salts of organic acids and mineral acids.
- salts include salts of organic acids such as formic acid, fumaric acid, acetic acid, propionic acid, lactic acid, oxalic acid, succinic acid, malonic acid, phthalic acid, fumaric acid, mandelic acid, methane-sulfonic acid, ethane-sulfonic acid, malic acid, tartaric acid, citric acid, benzoic acid, salicylic acid and the like.
- Suitable inorganic acid-addition salts include salts of hydrochloric acid, hydrobromic acid, sulphuric acid and phosphoric acid and the like.
- the acid addition salts may be obtained as the direct products of compound synthesis.
- the free base may be dissolved in a suitable solvent containing the appropriate acid, and the salt isolated by evaporating the solvent or otherwise separating the salt and solvent.
- the compound and salts are useful within human and veterinary medicine, for example, in the treatment of patients suffering from a sleep disorder and/or sleep disturbance.
- the compound and pharmaceutically acceptable salts are formulated with a pharmaceutically acceptable carrier to provide a medicament for parenteral, oral, nasal, rectal, subdermal or intradermal or transdermal administration according to conventional methods.
- Formulations may further include one or more diluents, fillers, emulsifiers, preservatives, buffers, excipients, etc. and may be provided in such forms as liquids, powders, emulsions, suppositories, liposomes, transdermal patches, controlled release, dermal implants, tablets, etc.
- One skilled in this art may formulate the compound in an appropriate manner, and in accordance with accepted practices, such as those disclosed in Remington's Pharmaceutical Sciences, Gennaro, ed., Mack Publishing Co., Easton, PA, 1990.
- the active compound is prepared in a form suitable for oral administration, such as a tablet or capsule.
- a pharmaceutically acceptable salt of the compound is combined with a carrier and moulded into a tablet.
- Suitable carriers include starch, sugars, dicalcium phosphate, calcium stearate, magnesium stearate and the like.
- Such compositions may further include one or more auxiliary substances, such as wetting agents, emulsifiers, preservatives, stabilizers, colouring additives, etc.
- compositions containing the compound may be administered one or more times per day or week.
- An effective amount of such a pharmaceutical composition is the amount that provides a clinically significant effect against one or more sleep disorders and/or disturbances. Such amounts will depend, in part, on the particular condition to be treated, age, weight, and general health of the patient, and other factors evident to those skilled in the art.
- a typical daily dosage is suitably from about 0.01 mg to about 100 g, preferably from about 1 to about 1000 mg, especially from about 10 to about 100 mg per patient per day.
- compositions containing the compound may be administered in unit dosage form one or more times per day or week.
- NNC 0756 (80 mg) and another dopamine D1 receptor antagonist, the compound of Example 4 (25 mg), were administered to two and three men, respectively. Serum concentrations of the compounds were measured 1.5 and 6.0 hours following oral administration of the compound of Example 1 and 1.5 and 8.0-8.8 hours following oral administration of NNC 0756.
- the compounds of the present invention have a shorter half life, making the compounds of the present invention useful in the treatment of sleep disorders and/or sleep disturbances.
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Epidemiology (AREA)
- Anesthesiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (4)
- Verwendung der Verbindung (+)-5-(2,3-Dihydrobenzofuran-7-yl)-7-hydroxy-3-methyl-8-nitro-2,3,4,5-tetrahydro-1H-3-benzazepin oder ein pharmazeutisch akzeptables Salz davon für die Herstellung einer pharmazeutischen Zusammensetzung für die Behandlung von oder Vorbeugung gegen Schlaffehlfunktionen und/oder Schlafstörungen.
- Verwendung nach Anspruch 1, bei der die Schlaffehlfunktion Schlaflosigkeit ist.
- Verwendung nach Anspruch 1 oder 2, bei der die genannte Zusammensetzung in einer für die orale Verabreichung geeigneten Form vorliegt.
- Verwendung nach Anspruch 1, 2 oder 3, bei der die genannte Verbindung in einer täglichen Dosis pro Patient im Bereich von 0,01 mg bis 100 g, vorzugsweise von 1 bis 1000 mg, besonders bevorzugterweise von 10 bis 100 mg verabreicht werden soll.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DK26597 | 1997-03-12 | ||
DK26597 | 1997-03-12 | ||
US4150997P | 1997-03-24 | 1997-03-24 | |
US41509P | 1997-03-24 | ||
PCT/DK1998/000088 WO1998040072A1 (en) | 1997-03-12 | 1998-03-11 | Use of 2,3,4,5-tetrahydro-1h-3-benzazepines for the manufacture of a pharmaceutical composition for the treatment of sleep disorders |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1011679A1 EP1011679A1 (de) | 2000-06-28 |
EP1011679B1 true EP1011679B1 (de) | 2003-07-30 |
Family
ID=26063641
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP98907896A Expired - Lifetime EP1011679B1 (de) | 1997-03-12 | 1998-03-11 | Verwendung von 8-nitro-2,3,4,5-tetrahydro-1h-3-benzazepinen zur herstellung von pharmazeutischen zusammenstellungen zur behandlung von schlafstörungen |
Country Status (16)
Country | Link |
---|---|
US (1) | US6211173B1 (de) |
EP (1) | EP1011679B1 (de) |
JP (1) | JP2001515484A (de) |
AT (1) | ATE245986T1 (de) |
AU (1) | AU742873B2 (de) |
BR (1) | BR9808234A (de) |
CA (1) | CA2283083C (de) |
CZ (1) | CZ296464B6 (de) |
DE (1) | DE69816832T2 (de) |
DK (1) | DK1011679T3 (de) |
ES (1) | ES2203933T3 (de) |
IL (1) | IL131670A (de) |
NO (1) | NO324719B1 (de) |
PL (1) | PL189822B1 (de) |
PT (1) | PT1011679E (de) |
WO (1) | WO1998040072A1 (de) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7504391B2 (en) * | 2003-05-22 | 2009-03-17 | Schering Corporation | Selective D1/D5 receptor antagonists for the treatment of obesity and CNS disorders |
DK1691811T3 (da) * | 2003-12-11 | 2014-10-20 | Sunovion Pharmaceuticals Inc | Kombination af et sedativ og en neurotransmittermodulator og fremgangsmåder til forbedring af søvnkvaliteten og behandling af depression |
WO2005063248A1 (en) * | 2003-12-22 | 2005-07-14 | Sepracor Inc. | Modafinil combination therapy for improving sleep quality |
WO2005063297A2 (en) * | 2003-12-24 | 2005-07-14 | Sepracor Inc. | Melatonin combination therapy for improving sleep quality |
ES2337700T3 (es) * | 2004-02-18 | 2010-04-28 | Sepracor, Inc. | Terapia combinada de agonista de dopamina con sedantes para mejorar la calidad del sueño. |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK325188D0 (da) * | 1988-06-15 | 1988-06-15 | Novo Industri As | Hidtil ukendte benzazepinderivater |
US5470850A (en) * | 1992-02-24 | 1995-11-28 | Novo Nordisk A/S | 2,3,4,5-tetrahydro-1H-3-benzazepines |
DK26793D0 (da) * | 1993-03-10 | 1993-03-10 | Novo Nordisk As | Benzofuranyl- eller dihydrobenzofuranyl-substituerede tricycliske benzazepiner, der anvendelse og fremstilling |
-
1998
- 1998-03-11 US US09/380,840 patent/US6211173B1/en not_active Expired - Fee Related
- 1998-03-11 ES ES98907896T patent/ES2203933T3/es not_active Expired - Lifetime
- 1998-03-11 AU AU66100/98A patent/AU742873B2/en not_active Ceased
- 1998-03-11 CA CA002283083A patent/CA2283083C/en not_active Expired - Fee Related
- 1998-03-11 EP EP98907896A patent/EP1011679B1/de not_active Expired - Lifetime
- 1998-03-11 WO PCT/DK1998/000088 patent/WO1998040072A1/en active IP Right Grant
- 1998-03-11 BR BR9808234-5A patent/BR9808234A/pt not_active Application Discontinuation
- 1998-03-11 DE DE69816832T patent/DE69816832T2/de not_active Expired - Lifetime
- 1998-03-11 PL PL98335545A patent/PL189822B1/pl not_active IP Right Cessation
- 1998-03-11 CZ CZ0317799A patent/CZ296464B6/cs not_active IP Right Cessation
- 1998-03-11 IL IL13167098A patent/IL131670A/xx not_active IP Right Cessation
- 1998-03-11 AT AT98907896T patent/ATE245986T1/de active
- 1998-03-11 DK DK98907896T patent/DK1011679T3/da active
- 1998-03-11 PT PT98907896T patent/PT1011679E/pt unknown
- 1998-03-11 JP JP53910298A patent/JP2001515484A/ja not_active Ceased
-
1999
- 1999-09-07 NO NO19994343A patent/NO324719B1/no not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
PT1011679E (pt) | 2003-12-31 |
BR9808234A (pt) | 2000-05-16 |
WO1998040072A1 (en) | 1998-09-17 |
IL131670A0 (en) | 2001-01-28 |
CZ296464B6 (cs) | 2006-03-15 |
NO994343D0 (no) | 1999-09-07 |
DE69816832D1 (de) | 2003-09-04 |
DE69816832T2 (de) | 2004-05-27 |
CA2283083C (en) | 2007-09-04 |
CA2283083A1 (en) | 1998-09-17 |
ES2203933T3 (es) | 2004-04-16 |
US6211173B1 (en) | 2001-04-03 |
JP2001515484A (ja) | 2001-09-18 |
PL335545A1 (en) | 2000-04-25 |
CZ317799A3 (cs) | 2000-03-15 |
NO994343L (no) | 1999-11-11 |
ATE245986T1 (de) | 2003-08-15 |
AU6610098A (en) | 1998-09-29 |
EP1011679A1 (de) | 2000-06-28 |
IL131670A (en) | 2005-07-25 |
NO324719B1 (no) | 2007-12-03 |
AU742873B2 (en) | 2002-01-17 |
PL189822B1 (pl) | 2005-09-30 |
DK1011679T3 (da) | 2003-11-24 |
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